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NCT00480974 Clinical Trial

Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

Sickle Cell Anemia Clinical Trial

Official title:
Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00480974
Other study ID # 5321006.EMC
Secondary ID
Status Completed
Phase N/A
First received May 31, 2007
Last updated September 3, 2009
Start date May 2007
Est. completion date December 2008

Study information
Verified date September 2009
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

Description:

Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 40 Years
Eligibility Inclusion Criteria:

- All patients treated by Hydroxyurea in the Pediatric Hematology Unit.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Clinical follow up and laboratory analysis
Clinical follow up and laboratory analysis

Locations
Country Name City State
Israel Pediatric Hematology Unit - HaEmek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

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